ERIVEDGE Drug Patent Profile

When do Erivedge patents expire, and when can generic versions of Erivedge launch?

Erivedge is a drug marketed by Genentech and is included in one NDA. There are three patents protecting this drug and one Paragraph IV challenge.

This drug has fifty-four patent family members in twenty-four countries.

The generic ingredient in ERIVEDGE is vismodegib. One supplier is listed for this compound. Additional details are available on the vismodegib profile page.

DrugPatentWatch^® Generic Entry Outlook for Erivedge

Erivedge was eligible for patent challenges on January 30, 2016.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be November 11, 2028. This may change due to patent challenges or generic licensing.

There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

Summary for ERIVEDGE

International Patents:	54
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	86
Clinical Trials:	46
Patent Applications:	4,536
Drug Prices:	Drug price information for ERIVEDGE
What excipients (inactive ingredients) are in ERIVEDGE?	ERIVEDGE excipients list
DailyMed Link:	ERIVEDGE at DailyMed

See drug prices for ERIVEDGE

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for ERIVEDGE

Constraining patent/regulatory exclusivity:

7,888,364

NDA:

203388

Dosage:

CAPSULE;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for ERIVEDGE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
H. Lee Moffitt Cancer Center and Research Institute	Early Phase 1
Genentech, Inc.	Early Phase 1
Ronald Buckanovich	Phase 2

See all ERIVEDGE clinical trials

Pharmacology for ERIVEDGE

Drug Class	Hedgehog Pathway Inhibitor
Mechanism of Action	Smoothened Receptor Antagonists

Paragraph IV (Patent) Challenges for ERIVEDGE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ERIVEDGE	Capsules	vismodegib	150 mg	203388	1	2025-03-27

US Patents and Regulatory Information for ERIVEDGE

ERIVEDGE is protected by three US patents.

This potential generic entry date is based on patent 7,888,364.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Genentech	ERIVEDGE	vismodegib	CAPSULE;ORAL	203388-001	Jan 30, 2012		RX	Yes	Yes	9,278,961
Genentech	ERIVEDGE	vismodegib	CAPSULE;ORAL	203388-001	Jan 30, 2012		RX	Yes	Yes	9,790,183
Genentech	ERIVEDGE	vismodegib	CAPSULE;ORAL	203388-001	Jan 30, 2012		RX	Yes	Yes	7,888,364		Y	Y

Expired US Patents for ERIVEDGE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Genentech	ERIVEDGE	vismodegib	CAPSULE;ORAL	203388-001	Jan 30, 2012	9,790,183

EU/EMA Drug Approvals for ERIVEDGE

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Roche Registration GmbH	Erivedge	vismodegib	EMEA/H/C/002602Erivedge is indicated for the treatment of adult patients with:- symptomatic metastatic basal cell carcinoma- locally advanced basal cell carcinoma inappropriate for surgery or radiotherapy	Authorised	no	no	no	2013-07-12	2013-04-26

International Patents for ERIVEDGE

See the table below for patents covering ERIVEDGE around the world.

Country	Patent Number	Title	Estimated Expiration
Norway	20071719
Australia	2013219216	Pyridyl Inhibitors of Hedgehog Signalling
South Korea	20200118909	헤지호그 신호전달에 대한 피리딜 억제제 (PYRIDYL INHIBITORS OF HEDGEHOG SIGNALLING)
Portugal	1789390

Supplementary Protection Certificates for ERIVEDGE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1789390	C20130027 00083	Estonia		PRODUCT NAME: VISMODEGIIB;REG NO/DATE: K(2013)4550 (LOPLIK) 12.07.2013
1789390	122013000074	Germany		PRODUCT NAME: ERIVEDGE - VISMODEGIB; NAT. REGISTRATION NO/DATE: EU/1/13/848 20130712; FIRST REGISTRATION: SCHWEIZ IKS-NR. 62497 20130530
1789390	PA2013024,C1789390	Lithuania		PRODUCT NAME: VISMODEGIBUM; REGISTRATION NO/DATE: EU/1/13/848 20130712
1789390	92278	Luxembourg		PRODUCT NAME: VISMODEGIB ET SES DERIVES PHARMACEUTIQUEMENT ACCEPTABLES (ERIVEDGE ); AUTHORISATION NUMBER AND DATE: 62497

Market Dynamics and Financial Trajectory for ERIVEDGE (Vismodegib): An In-Depth Analysis

Last updated: December 7, 2025

Executive Summary

ERIVEDGE (vismodegib) is an FDA-approved targeted therapy for basal cell carcinoma (BCC), including both locally advanced and metastatic forms. Since its approval in 2012 under the brand name ERIVEDGE, the drug has carved a niche within the oncological ecosystem, driven by increasing incidences of BCC, advances in precision medicine, and evolving treatment paradigms. This comprehensive analysis explores the market landscape, key drivers, competitive positioning, regulatory influences, and future financial trajectory of ERIVEDGE.

What Are the Core Applications and Therapeutic Indications for ERIVEDGE?

Therapeutic Indication	Description	Approval Year	Market Penetration
Locally Advanced Basal Cell Carcinoma (laBCC)	Unresectable or patient-unfit for surgery	2012 (FDA); 2013 (EMA)	Initial focus segment
Metastatic Basal Cell Carcinoma (mBCC)	Patients with advanced disease	2012	Niche segment

Source: FDA Approval Details[1]

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What Is the Current Market Size and Growth Potential for ERIVEDGE?

Global Incidence of Basal Cell Carcinoma

Region	Estimated New Cases (2022)	CAGR (2010-2022)	Key Factors
North America	2.4 million	3.5%	High UV exposure, aging population
Europe	1.5 million	3.2%	Increased aging demographics
Asia-Pacific	1.2 million	4.5%	Rising awareness, urbanization
Rest of World	0.5 million	4.8%	Access to healthcare, diagnostic advances

Total global new cases in 2022: Approximately 5.6 million.

Market Size Estimates (2022)

Parameter	Value (USD Millions)	Notes
ERIVEDGE sales (Global)	~$150 million	Including prescriptions for laBCC and mBCC
North America	$120 million	Major revenue contributor
Europe	$20 million	Growing but limited due to competition
Asia-Pacific	$7 million	Emerging market, lower penetration

Growth Forecast: A compound annual growth rate (CAGR) of approximately 10-12% projected through 2027, driven by rising BCC incidence and expanded indications.

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What Are the Key Market Drivers for ERIVEDGE?

1. Rising BCC Incidence

• The US CDC reports a 10-year recurrence rate of 35-50% for BCC, indicating a persistent patient pool.
• Aging populations in developed markets enhance overall prevalence.

2. Advances in Precision Oncology

• Vismodegib's mechanism targeting the Hedgehog pathway aligns with broader shifts toward personalized medicine.
• Encourages off-label and expanded uses in related tumors.

3. Expanding Indications & Approvals

• Discussions around neoadjuvant use and adjuvant settings.
• Ongoing clinical trials exploring vismodegib in other Hedgehog pathway-related malignancies (e.g., medulloblastoma).

4. Regulatory and Reimbursement Policies

• Favorable policies in the US, with CMS coverage for specific indications.
• Price controls remain moderate, supporting sustained revenue.

5. Competitive Differentiation

Key Competitor	Market Position	Differentiator
Sonidegib (Odomzo)	Alternative Hedgehog pathway inhibitor	Oral administration, different side effect profile
Cemiplimab (Libtayo)	Immunotherapy competitor	Different mechanism, broader oncology label

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What Challenges Could Impact ERIVEDGE's Market & Financial Performance?

1. Competitive Landscape

• Increased competition from other Hedgehog inhibitors and immunotherapies.
• Potential biosimilar entries after patent expiry.

2. Safety and Side Effect Profile

• Common adverse effects: muscle spasms, alopecia, dysgeusia, weight loss.
• Patient discontinuation or contraindications can limit market share.

3. Market Saturation & Off-label Use

• Saturation in primary indications.
• Off-label prescribing risks may limit revenue growth or provoke regulatory scrutiny.

4. Patent Expiries & Generic Entry

• Patent expiry anticipated around 2025, risking significant erosion of market exclusivity.

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How Is the Regulatory Environment Shaping ERIVEDGE's Future?

Region	Key Regulations	Impact on Market	Noteworthy Notes
U.S.	FDA approvals for laBCC and mBCC	Market expansion	REMS (Risk Evaluation and Mitigation Strategy) in place
EU	EMA approvals	Market access	Slight delays in labeling updates
Japan & Asia	Regulatory approvals	Entry into emerging markets	Local clinical data requirements

Insights

• Regulatory frameworks support expanded indications with fast-track and orphan drug designations.
• Cost-effectiveness and value-based assessments influence formulary decisions, particularly in payor-sensitive markets.

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What Is the Financial Trajectory for ERIVEDGE?

Revenue Projections (2022-2027)

Year	Estimated Revenue (USD Millions)	Growth Rate	Assumptions
2023	~$165 million	+10%	Continued penetration, new regional approvals
2024	~$180 million	+9%	Market expansion, off-label use mitigation
2025	~$200 million	+11%	Patent expiry approaches, biosimilar competition
2026	~$210 million	+5%	Market saturation, price pressure
2027	~$220 million	+4%	Maturity, new clinical data

Key Revenue Drivers

• Increased incidence and diagnosis rates.
• Launch in new markets (e.g., China, Japan).
• Possible label expansion for neoadjuvant or combination therapy.

Cost Considerations

• R&D investments in new indications.
• Manufacturing and supply chain expenses.
• Marketing and payer engagement costs.

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How Does ERIVEDGE Compare With Its Competitors?

Attribute	ERIVEDGE	Sonidegib (Odomzo)	Cemiplimab (Libtayo)
Mechanism	Hedgehog pathway inhibitor	Hedgehog pathway inhibitor	PD-1 inhibitor (immunotherapy)
Administration	Oral	Oral	Intravenous
Approval Years	2012	2015	2018
Indications	laBCC, mBCC	laBCC, mBCC	laBCC, squamous cell carcinoma
Side Effects	Muscle spasms, alopecia	Similar	Fatigue, immune-related adverse events
Market Share (2022)	~80% in BCC	15-20%	Emerging

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What Are Critical Success Factors for ERIVEDGE's Future?

• Enhanced Clinical Data: Demonstrating efficacy in new indications or combination therapies.
• Market Expansion: Penetration into Asia-Pacific and emerging markets.
• Cost Management: Navigating patent expiry with strategies for biosimilar competition.
• Regulatory Engagement: Accelerating approvals and label expansions.
• Patient Support Initiatives: Improving adherence and minimizing side effects.

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Key Takeaways

• Growing Incidence: The global BCC burden underscores significant market potential for ERIVEDGE, especially in aging populations and UV-exposure regions.
• Market Expansion: North America dominates, but Asia-Pacific and Europe present substantial headroom for growth, contingent on regulatory receptivity.
• Competitive Landscape: While ERIVEDGE currently retains a strong position, patent expiries and emerging therapies threaten market share.
• Regulatory & Policy Dynamics: Favorable, but evolving policies necessitate proactive engagement to maintain market access.
• Financial Outlook: Projected steady growth through 2027, with potential for acceleration through clinical trials and indications expansion, tempered by market saturation and biosimilar competition.

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FAQs

1. When is ERIVEDGE expected to go off patent, and how will it impact revenue?
Patent protections are expected to expire around 2025, likely leading to biosimilar entry and significant revenue erosion unless the developer diversifies indications or innovates new formulations.

2. Are there ongoing clinical trials that could expand ERIVEDGE’s approved use?
Yes. Trials are investigating vismodegib in combination with other agents, in neoadjuvant settings, and outside traditional BCC indications, which could broaden its therapeutic footprint.

3. How do side effects influence ERIVEDGE’s market adoption?
Adverse effects like muscle spasms and alopecia can limit patient adherence but are generally manageable with supportive care strategies. Their impact on treatment discontinuation remains a key concern.

4. What role do regulatory policies play in ERIVEDGE’s market trajectory?
Favorable policies, including orphan drug designations and expedited review pathways, facilitate faster approvals and market access, supporting revenue growth.

5. How does ERIVEDGE compare to immunotherapies in BCC treatment?
While ERIVEDGE targets the Hedgehog pathway, immunotherapies like cemiplimab offer alternative mechanisms. The choice depends on patient profile, prior therapies, and side effect considerations, with ERIVEDGE remaining the first-line targeted agent for laBCC/mBCC.

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References

[1] FDA. (“Vismodegib (Erivedge) Approval Summary.” 2012).
[2] European Medicines Agency. (“Vismodegib (Erivedge) EMEA Summary.” 2013).
[3] CDC. (“Basal Cell Carcinoma Incidence Data.” 2022).
[4] IQVIA. (“Global Oncology Market Report.” 2022).
[5] Company Reports & Clinical Trials Registries.

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This analysis offers business professionals an in-depth understanding of ERIVEDGE’s market position, growth outlook, and strategic considerations essential for investment, development, or competitive decision-making.